The following data is part of a premarket notification filed by Airstrip Technologies, Inc. with the FDA for Airstrip One Web Client With Alarm Communication Management (acm).
Device ID | K211949 |
510k Number | K211949 |
Device Name: | AirStrip ONE Web Client With Alarm Communication Management (ACM) |
Classification | System, Network And Communication, Physiological Monitors |
Applicant | AirStrip Technologies, Inc. 2915 West Bitters Road, Suite 215 San Antonio, TX 78248 |
Contact | Jf Lancelot |
Correspondent | Jf Lancelot AirStrip Technologies, Inc. 2915 West Bitters Road, Suite 215 San Antonio, TX 78248 |
Product Code | MSX |
CFR Regulation Number | 870.2300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-06-23 |
Decision Date | 2021-12-09 |